In this war, doctors need freedom to use the ‘weapons’ at hand

By Elizabeth Lee Vliet, M.D.

Note: Dr. Vliet is a member of the Association of American Physicians and Surgeons, AAPS.

A recent poll of more than 6,000 doctors from 30 countries found that 37% rated hydroxychloroquine (HCQ) as the best treatment for novel coronavirus disease (COVID-19).

Yet, during a recent webinar on COVID-19, doctors across the United States described threats from many governors and state medical boards for prescribing HCQ and azithromycin “off label” for non-hospitalized COVID-19 patients.

It was shocking to hear that our front-line warriors are not only having their medical decisions blocked, but are being threatened with disciplinary actions, and even loss of license in some states.

The international poll conducted by Sermo highlighted crucial differences between the U.S. and other countries. Many fewer U.S. physicians – only 23 percent – had prescribed HCQ, while 72 percent of Spanish physicians used it as their first choice for COVID-19. Also, in the U.S. it was most commonly used for hospitalized, high-risk patients with severe symptoms, while in other countries it was equally used for out­patients with mild symptoms at the onset of disease.

HCQ has been FDA-approved for malaria since World War II, and it is now also approved for treating lupus and rheumatoid arthritis.

These findings mean the U.S. lags behind other countries in using HCQ to prevent infection, to reduce the time that a person sheds virus and can infect others, and to keep patients out of hospitals and off ventilators.

Basic science and clinical outcomes studies from more than 10 countries show that HCQ works both before and after COVID-19 enters the cells. It increases zinc transport across the cell membrane, and the two work together to keep the virus from multiplying itself using our own cells’ machinery.

It is the viral multiplication or replication that triggers the inflammatory cascade, or cytokine storm that damages organs, especially the lungs leading to the acute respiratory distress syndrome (ARDS) and deaths.

Adding the antibiotic azithromycin, or possibly doxycycline for elderly with contraindications, shows a synergistic effect, as reported from France, China and several clinical outcomes studies in the U.S.

A new 2020 study showed an additional way HCQ works: It prevents the virus from attaching to host cell surface molecules. The authors conclude: “Our data do support the use of chloroquine and preferentially hydroxychloroquine as a first intention therapy for patients infected with SARS-CoV-2 (COVID-19).”

On March 28, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization for HCQ to treat COVID-19 – but restricted this approval to hospitalized patients.

That restriction means loss of the critical early window of opportunity to achieve four urgent goals to stop the pandemic: 1) prevent the virus attaching to host cells; 2) reduce viral replication that prolongs time of infectivity and spread; 3) reduce the number of hospitalizations and need for intubation and mechanical ventilators; and 4) reduce risk of multi-organ damage and death or permanent lung impairment after recovery.

At the April 4 Coronavirus Task Force briefing, reporters continually focused on the potential shortage of ventilators, yet no one was asking about using effective medication approaches to keep patients from becoming so critically ill that they need mechanical ventilation.

When World Health Organization and U.S. experts say there is “no evidence that any medicine can prevent or cure” COVID-19, they correctly mean We don’t yet have a randomized, placebo-controlled, double blind clinical trial (RCT). But designing, setting up, conducting and analyzing any RCT takes years. And that is only one form of evidence in medicine. Case studies (pejoratively called “anecdotes”) and decades of safe use worldwide provide other valid sources of clinical outcomes evidence, which have guided physicians for more than 2,000 years.

As a matter of historical record, we had no RCT “proving” that smoking caused lung cancer, but that did not stop common-sense recommendations by the surgeon general and physicians who advised patients to stop smoking cigarettes, based on clinical outcomes showing higher lung cancer and heart attack deaths in smokers.

We have no time for an RCT. We can’t wait months for a vaccine. People are dying every day. Staggering numbers of people have lost jobs, incomes and ability to live life normally. We cannot ignore the well-known fact that times of massive unemployment lead to lost lives, from drug addiction, depression/suicide, domestic violence and losing access to medical care. These losses could exceed those from the virus if the country remains shut down for a prolonged period. This is real damage, not just theoretical, and it is escalating every day.

In this war against the invisible virus, doctors – our soldiers on the front line – simply must be free to use the medicines at hand, to the best of their ability and judgment for each patient, free of politicians and bureaucrats’ second-guessing and threats.

Doctors must be able to prescribe, pharmacists to dispense and patients to take already approved drugs for this novel use against a novel enemy. About 20% of all prescriptions are for “off-label” uses. The FDA may restrict pharmaceutical companies’ marketing for off-label uses, but it has no authority to interfere with doctors’ prescribing them off-label. That is called the practice of medicine. It is unprecedented – and lethal – for state governors and medical boards to forbid the freedom to prescribe long-approved and safely used medications.

America urgently needs a presidential directive to remove the FDA’s red tape and state political obstacles to save lives and reduce the rate of spread of COVID-19. Hospitals must quickly be fully opened to treat patients with urgent medical and surgical needs beyond COVID-19 to avoid losing hospitals and medical staff. We should consider India’s approach with a national recommended guide for physicians. Stop this patchwork quilt of governors’ arbitrarily deciding what prescriptions can and cannot be used in each state.

In a war to save lives and our country, we must fight with all the weapons we have at hand, even if not yet “proven.”

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